首页|起始联合降脂策略对心内科门诊"极高危ASCVD"患者疗效及安全性观察——真实世界的前瞻性队列研究

起始联合降脂策略对心内科门诊"极高危ASCVD"患者疗效及安全性观察——真实世界的前瞻性队列研究

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目的:在真实世界的前瞻性队列研究中观察心内科门诊"极高危ASCVD"患者在治疗起始阶段采用联合降脂策略的疗效与安全性。方法:连续入组2021年1月至6月在湘雅医院心内科高脂血症专病门诊就诊的"极高危ASCVD"患者，根据其实际降脂策略分为三组:阿托伐他汀单药组;阿托伐他汀联合依折麦布组;阿托伐他汀联合依洛尤单抗组。主要观察终点为治疗一个月后低密度脂蛋白胆固醇(LDL-C)、脂蛋白a[Lp(a)]、非-HDL-C变化，次要终点为总胆固醇(TC)、甘油三酯(TG)、LDL-C、超敏C反应蛋白(hs-CRP)变化及安全性指标。结果:无论哪种联合方式，在"极高危ASCVD"患者降脂起始阶段联合降脂治疗的疗效均显著优于阿托伐他汀单药组:LDL-C、Log[Lp(a)]、非-HDL-C、TC的降幅更大，差异均有统计学意义(均P＜0。05)。在两种联合降脂方案中，阿托伐他汀联合依洛尤单抗与联合依折麦布相比，LDL-C、Log[Lp(a)]的降幅更大，差异均有统计学意义(P＜0。05)，TC、TG有一定的降幅，差异无统计学意义(P＞0。05)。以"LDL-C＜1。4 mmol/L或＜1。8 mmol/L"作为降脂达标的标准时，两组联合降脂治疗的LDL-C达标率均高于阿托伐他汀单药组，差异均有统计学意义(均P＜0。05);阿托伐他汀联合依洛尤单抗组的LDL-C达标率高于阿托伐他汀联合依折麦布组，差异均有统计学意义(均P＜0。05)。单独或联合"LDL下降超过50％"的降幅为达标标准，三组均无人能达标。治疗后三组间的肝脏转氨酶水平变化差异均无统计学意义(均P＜0。05);三组间心肌酶同工酶(CK-MB)均下降，但差异无统计学意义(P＜0。05)。与阿托伐他汀单药组相比，两联合降脂组治疗组的血糖均下降，差异具有统计学意义(P＜0。05);阿托伐他汀联合依折麦布组的血糖比阿托伐他汀联合依洛尤单抗组的降幅更大，差异有统计学意义(P＜0。05)。结论:起始联合降脂治疗1个月对心内科门诊"极高危ASCVD"患者的降脂效果及LDL-C的达标率优于阿托伐他汀单药组。以LDL-C＜1。4 mmol/L或＜1。8 mmol/L为降脂达标目标时，阿托伐他汀联合依洛尤单抗组治疗1个月后LDL-C达标率高于联合依折麦布组;以"LDL下降超过50％"的降幅作为降脂达标标准时，1个月内很难达标。门诊"极高危ASCVD"患者采用起始联合的降脂治疗1个月无不良反应。起始联合降脂策略可用于心内科门诊"极高危ASCVD"患者中LDL-C数值需早期达标的人群，阿托伐他汀联合依洛尤单抗可用于需在 1 个月内 LDL-C＜1。4 mmol/L或＜1。8 mmol/L 的人群。
Observation on the efficacy and safety of initial combined lipid-low-ering strategy in patients with"very high-risk ASCVD"in cardiology outpatient department:real-world prospective cohort study
AIM:To observe the efficacy and safe-ty of combined lipid-lowering strategies in the ini-tial stage of treatment in"very high-risk ASCVD"pa-tients in cardiology outpatient clinics in a real-world prospective cohort study.METHODS:Pa-tients with"very high-risk ASCVD"from January to June 2021 were consecutively enrolled and divided into three groups according to the actual lipid-low-ering treatment strategies:Atorvastatin group;Atorvastatin combine with ezetimibe group;Atorv-astatin combine with evolocumab group.The pri-mary observation endpoints were the changes in LDL-C,Lp(a),and non-HDL-C after one month of treatment,and the secondary endpoints were the changes in TC,TG,HDL-C,Hs-CRP,and safety indica-tors.RESULTS:The efficacy of the combined lipid-lowering strategy in the initial stage of treatment was significantly better than that of the Atorvas-tatin group:LDL-C,Log[Lp(a)],non-HDL-C,TC sig-nificantly decreased(all P＜0.05).Compared with the Atorvastatin combine with Ezetimibe group,LDL-C and Log[Lp(a)]decreased significantly in the Atorvastatin combine with Evolocumab group(P＜0.05),and TC and TG had decreased insignifi-cantly(P＞0.05).When"LDL-C＜1.4mmol/L or＜1.8 mmol/L"is used as the standard for lipid-low-ering compliance,the LDL-C compliance rates of the two groups of combined lipid-lowering treat-ments are higher than those of the atorvastatin sin-gle-drug group.The differences were all statistically significant(all P＜0.05);the LDL-C compliance rate of the atorvastatin combined with evolocumab group was higher than that of the atorvastatin com-bined with ezetimibe group,and the differences were statistically significant(All P＜0.05).When the reduction rate of"LDL dropped by more than 50％"alone or in combination were used as the standard,no one in the three groups could reach the stan-dard.The liver aminotransferase levels had no signif-icant changes among the 3 groups after treatment(all P＞0.05).Myocardial enzyme isoenzyme(CK-MB)decreased among the 3 groups insignificantly(P＞0.05).Compared with the Atorvastatin group,the blood sugar(BS)of the two combined lipid-low-ering groups decreased significantly(P＜0.05);The BS of the Atorvastatin+ezetimibe group significant-ly decreased than that of Atorvastatin combine with Evolocumab group(P＜0.05).CONCLUSION:The lipid-lowering effect and LDL-C compliance rate of patients with"very high-risk ASCVD"in the cardi-ology outpatient department after 1 month of com-bined lipid-lowering treatment were better than those of the atorvastatin monotherapy group.When LDL-C＜1.4 mmol/L or＜1.8 mmol/L is the lip-id-lowering target,the LDL-C compliance rate after 1 month of treatment in the atorvastatin combined with evolocumab group is higher than that of the combined atorvastatin and zetamibu group.When the"LDL drop by more than 50％"is used as the standard for lipid lowering,it is difficult to reach the standard within 1 month.Outpatient"very high-risk ASCVD"patients were treated with initial combined lipid-lowering therapy for 1 month with-out adverse reactions.The initial combined lipid-lowering strategy can be used for patients with"very high-risk ASCVD"in cardiology outpatient clinics who need to achieve LDL-C values early.Atorvastatin combined with evolocumab strategy can be recommended for those patients who re-quire LDL-C＜1.4 mmol/L or＜1.8 mmol/L within one month.

initial combined lipid lowering strate-gyvery high-risk ASCVDreal worldprospective cohort studyearly achievement

赵震宇、李媛、郭宇轩、毛萧萧、Md Sayed Ali Sheikh、夏珂

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中南大学湘雅医院临床药理研究所

中南大学湘雅医院心血管内科,长沙 410008,湖南

Internal Medicine Department,Cardiology,College of Medicine,Jouf University,Sakaka 72388,Saudi Arabia

起始联合降脂 极高危ASCVD 真实世界 前瞻性队列研究 早期达标

湖南省科技重大专项基金湖南省自然科学基金湖南省卫生健康委基金中国心血管健康联盟-2020进·阶基金

2021SK10202023JJ309482022030146872020-CCA-ACCESS-117

2024

10.12092/j.issn.1009-2501.2024.08.008

中国临床药理学与治疗学
中国药理学会

中国临床药理学与治疗学

CSTPCD北大核心
影响因子：0.97
ISSN：1009-2501
年,卷(期)：2024.29(8)